Novarad’s OpenSight Augmented Reality System By: Eric M. Luyer, Sr. Market Analyst In June 2016, I wrote an article around the use of Augmented Reality in Today’s Operating Rooms and I used the example of Google Glass as a new technology that helps improve surgical efficienciesRead More…

Webinar Now Available On-Demand By: Sandra K. Rodriguez, Market Analyst Compliance with Medical Device Regulation 2017/745/EU also commonly referred to as EU MDR, is presenting a significant challenge for the medical device industry. Medical device companies are set to experience an enormous impact on allRead More…

Tina Morrison, PhD, Deputy Director, Division of Applied Mechanics and Chair of FDA’s Modeling and Simulation Working Group recently presented initiatives underway at the agency to advance the use of Modeling and Simulation. FDA routinely advises industry on using modeling and simulation to, for example: PredictRead More…

This week, Scott Gottlieb, MD Deputy Commissioner for Medical and Scientific Affairs at the Food and Drug Administration made an interesting speech before the 2006 Conference on Adaptive Trial Design in Washington, DC.Dr Gotlieb commented how today’s clinical trials are highly empirical. Drugs are tested on general populations for a response and a treatment effect that is statistically not likely to be a chance result. This approach is rigorous and focused, but inflexible. According to Dr. Gotlieb, “another problem with the empirical approach is that it yields statistical information about how large populations with the same or similar conditions are likely to respond to a treatment. But doctors don’t treat populations, they treat individual patients. Doctors need information about the characteristics that predict which patients are more likely to respond well, or suffer certain side effect. The empirical approach doesn’t tell doctors how to personalize their care to their individual patients.” This results in a highly empirical approach to the practice of medicine. Gone are the days of: Take two off these and call me in the morning. Gottlieb comments “Doctors prescribe treatments knowing full well that only a certain percentage of their patients will receive a benefit from any given medicine.” This approach is akin to: Take all of these and call me if you have a side-effect.

But with the demands for personalized medicine and the advent of Pharmaco-genomics, there are potentially better alternatives. By enabling more trials to be adapted based on knowledge about gene and protein markers or patient characteristics, we can help predict whether patients will respond well to a new medicine. “These new approaches to clinical trials can result in trial designs that tell us more about safety and benefits of drugs, in potentially shorter time frames, exposing fewer people to experimental treatments, and resulting in clinical trials that may not only be more efficient but are more attractive to patients and their physicians to enroll in.” said Gottlieb. This is only a first step in the process to develop more adaptive clinical trials. This process will lead to more targeted therapies and in turn, Ii is my hope, more personal and personalized medicine.

During my senior year, I was lucky to have a few job offers to evaluate. The top two were from Johnson & Johnson and Exxon. As part of my research I looked at how each company handled adversity. For me it was an easy choice when I compared J&J’s handling of the Tylenol situation vs. Exxon’s Valdez. I was drawn by the impact I could make in people’s lives and by the industry’s reputation in general and J&J’s in particular.

But in recent years, our industry has gone though some tough times. We’ve have seen record FDA fines, product recalls and withdrawals as well as the erosion of consumer confidence. In my opinion executives at some Life-Science companies lost focus on the patient and began to concentrate on profits for Wall Street.

It is in times like these that we must reach for our roots and reflect on the legacy left by our industry’s founders.

In the August 1952 Time magazine interview, George W. Merck said “Medicine is for people, not for profits.” He went on “…if we remembered that, the profits have never failed to appear. The better we remembered, the larger they have been.”

In 1943 General Robert Wood Johnson wrote: “We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services.” This Credo is still etched in stone at the J&J world Headquarters.In 1899 Charles Pfizer said, “Our goal, has been and continues to be the same: to find a way to produce the highest-quality products and to perfect the most efficient way to accomplish this, in order to serve our customers. This company has built itself on its reputation and its dedication to these standards, and if we are to celebrate another 50 years, we must always be aware that quality is the keystone.”

In this post Sarbanes-Oxley era, I am heartened to see that our industry is once again putting patients first.

Let us remember to chase after the cures for human ailments, then and only then will fair profits follow.

It’s 3:00 AM and your newborn baby wakes up crying. You want to go back to sleep, but his circadian rhythm is set for Beijing, not Philadelphia, and he is wide awake.So you get a cup of coffee, turn on your laptop and start to do some work. In a moment of inspiration, you discover the cure for the common cold. It’s all there on the screen right in front of your eyes and then your baby kicks, the coffee spills on your laptop and, just like that, the cure is gone.Who do you call?

Monday, at the Corporate Computing Show in NY, I met the people for the job. DriveSavers Data Recovery is a company that recovers data from crashed and damaged media. They have been doing this for over 20 years and when James Bond looses the data in his laptop he doesn’t call Q. Instead he deals with Kelly Chessen, Data Crisis Counselor DriveSavers (Yes, Sean Connery is a client).

With the prospect of irretrievable information loss, many of the callers with whom Chessen deals are as distraught. The emotional trauma associated with the loss of critical data can be disruptive both at work and at home.

Chessen came to DriveSavers with a background in psychology that serves her well in her dealings with often-frantic customers. She worked with a suicide prevention hotline for more than five years, including one year as the manager and trainer. This is exactly the kind of training I want the person on the other end of the line to have under these circumstances.

In addition to the soft skills, DriveSavers has technical skills and facilities to back them up. They have recovered data from drives that have been damaged, dropped, deleted, burnt, crushed and drowned in the Amazon River. The company has a success rate of over 90%, and recovers data in as little as 24 hours from all operating systems and storage media including hard drives, disk arrays, floppies, CD-ROM, DVD, removable cartridges and digital camera media. They have they own calls 100 clean room, and if they work on your drive, the manufacturer’s warranty is still good, although I’m not sure that a drive full of Amazon River water is covered.

So the next time your husband, wife, son, daughter, dog, cat or self spill a cup of coffee on your laptop containing the cure for the common cold, or the therapeutic area you are working on, don’t sweat it, lay on the couch and call the Data Shrink.

Johnson & Johnson already had the title of the world’s most comprehensive and broadly based manufacturer of health care products, but with today’s announcement, it also becomes the World’s Premier Consumer Health Care Company.

With the levels of disposable income in developing nations increasing, and the profit margins for prescription drugs and decreasing, the acquisition provides a strong diversified footing for J&J in the healthcare arena. As consumers take greater interest and responsibility for their own health, OTC products are an attractive compliment to Johnson and Johnson’s Pharmaceutical and Medical Device sectors.

This acquisition continues J&J’s long standing practice of broad diversification in the Life-Sciences and Healthcare markets. “Being broadly based in health care allows us to leverage our expertise in science and technology across our businesses,” Weldon said. “Through this acquisition, we look to benefit both from Pfizer Consumer Healthcare’s excellent product portfolio and pipeline and from the valuable skills and experience of its employees.”

As our world continues to flatten, it is key to look at emerging markets as consumers not just producers.

According to the Food, Drug, and Cosmetic Act, FDA statutorily required to inspect domestic drug manufacturing establishments at least once every 2 years.

There is just one problem, the number or registered human drug establishments has increased in the last 25 years while the number of FDA human drug inspections has decreased over the same period. To address this issue, the FDA has implemented the “Risk-Based Method for Prioritizing CGMP Inspections of Pharmaceutical Manufacturing Sites”. This model, commonly known as the Site Selection Model, utilizes a risk-based inspection approach for prioritizing drug manufacturing establishments for routine cGMP inspection. The model is based on a risk-ranking and filtering method that is well-recognized, objective, and rigorously systematic. Currently there are 3 empirical factors used to calculate a site’s selection score.

They are:

Product Risk: Factors such as sterility, medical gas, and the determination of prescription (Rx) versus over the counter (OTC) currently in the model are crude surrogates to distinguish between products with higher and lower potential for public health consequence should there be a drug defect.

Process Risk: Some processes are more complex and more susceptible to problems than other processes. The key issues in the implementation of the risk-ranking model involves questions concerning the relevant inherent process risk factors, the relevant process control and risk mitigation factors, and how to weigh/rank them

Facility Risk:Currently, the facility component of the risk ranking model includes 4 factors:

History of violation (e.g., CGMP deficiencies have higher weights)

History of inspection (e.g., no prior inspection, newly registered/licensed or no CGMP inspection in the past 2 years have higher weights than those with recent CGMP inspection)

Estimated volume of production output (surrogate for exposure, e.g., higher volume and production output, higher weights)

Type of establishment (e.g., manufacturer, repacker, contract lab)

According to Joseph Famulare, acting Director of CDER’s office of compliance, in addition to these three empirical factors, “expert elicitation with emphasis on current FDA priorities is used to determine site selection”. “For example, last year trans-dermal patches were a priority at the agency” said Famulare, so the number of inspection in that area increased.

Famulare said “just under 50% of the cGMP inspections last year were based on the Site Selection Model, with the remainder done at the districts discretion.”

Next year, a new category will be factored in the empirical portion of the calculation. Recall data has already been entered in the database and will be used for Site Selection Model.

You heard about your credit score, it’s time to keep and eye on your Site Selection Score.

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